BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    MTS Gepotidacin 0.016-256 µg/mL

    K Number: K260696 · Decision Apr 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    35
    Review Days
    45

    Basic Information

    Device Name
    MTS Gepotidacin 0.016-256 µg/mL
    K Number
    K260696
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Liofilchem s.r.l.
    Date Received
    March 3, 2026
    Decision Date
    April 17, 2026
    Product Code
    JWY
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JWY Manual Antimicrobial Susceptibility Test Systems

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    Other Clearances by Liofilchem s.r.l.

    K Number Device Name
    K252114 MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL
    K251580 MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)
    K243202 MTS Ceftobiprole 0.002-32 µg/mL
    K230479 ComASP Cefiderocol 0.008-128
    K211672 MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
    K200180 MTS Omadacycline 0.002 - 32 ug/mL
    K192345 MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL
    K191908 MTS Imipenem 0.016-256 µg/mL
    K191809 MTS Imipenem-relebactam 0.002/4-32/4 µg/mL
    K190914 MTS Doxycycline 0.016 - 256 µg/mL
    Search all 35 clearances from Liofilchem s.r.l. →